Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.

Eligibility criteria

Qualifiers

Participants must be >18 years old at time of diagnosis

Histologically confirmed non-small cell lung cancer

ECOG PS 2

Clinical staging of IIIc or IV disease.

Disqualifiers

Patients with history of autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis

Patients on immunosuppressive medication, including steroids (if doses exceed equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to start of treatment are acceptable.

Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy and/or immunotherapy per the treating investigator.

The patient must not be on any clinical trials involving other experimental therapies during study treatment

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Pemetrexed (Chemotherapy)
  • Nab-paclitaxel (Chemotherapy)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators